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Cedars-Sinai Clinical Research Coordinator III - Haile Lab - Cancer Institute in West Hollywood, California

Developed as a part of the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai, the Research Center for Health Equity conducts a wide range of research, from molecular/genetic to behavioral, and research-driven community outreach and engagement (COE). COE efforts focus on compliance with cancer screening guidelines and major behavioral and lifestyle factors, such as physical activity, tobacco cessation and dissemination of the latest, most accurate cancer information. To increase effectiveness and extend our reach, the Center has established partnerships with many diverse community organizations in Los Angeles county and statewide. The center has also established research consortia at the statewide, national, and international levels.

Join the Research Center for Health Equity Team!

The Clinical Research Coordinator III - Haile Lab works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research staff. Plans and coordinates strategies for increasing patient enrollment, especially from Latinx communities, improving efficiency, training of personnel, and identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). This position will also require community engagement activities and the provision of phlebotomy services and limited blood sample processing. Fluency in English and Spanish is required. Experience working with diverse Latinx groups in the target area/community.

Primary Duties and Responsibilities:

  • Supervises other research staff in day to day operations. Provides input in the performance review of other clinical research staff.

  • Performs patient sampling (including providing phlebotomy service to obtain blood sample), performing laboratory-based sample processing.

  • In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.

  • Maintains accurate source documents related to all research procedures.

  • Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.

  • Schedules and participates in monitoring and auditing activities.

  • Scheduling of patients for research visits and procedures.

  • Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.

  • Notifies direct supervisor about concerns regarding data quality and study conduct.

  • Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.

  • May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.

  • Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.

  • Maintains research practices using Good Clinical Practice (GCP) guidelines.

  • Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

  • Participates in required training and education programs.

  • Works with Training and Education Coordinator to ensure all staff is properly trained and certified.

  • Participate in centralized activities such as auditing, Standard Operating Procedure development, etc.

  • Plans and coordinates strategies for increasing patient enrollment, and/or improving clinical research efficiency.

  • Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.

  • Identifies new research opportunities and presents to investigators.

Educational Requirements:

  • Bachelor's Degree, required

  • Degree in Science, Sociology, Medicine or related degree, preferred

License/Certification:

  • SOCRA or ACRP certification - Preferred

  • Certification as Phlebotomy Technician I (certificate may be obtained post-hire)

Experience:

  • 7 Years Related Experience

  • Fluency in Spanish and English languages and knowledge of Latinx cultures is required

Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.

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